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NOPR National Oncologic PET Registry

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Title: NOPR National Oncologic PET Registry


1
NOPRNational Oncologic PET Registry
2
Medicare Reimbursement for Oncologic PET (2005)
  • Diagnosis, staging, and restaging of
  • Non-small cell lung cancer Lymphoma
  • Esophageal cancer Malignant melanoma
  • Colorectal cancer Head and neck cancer
  • Staging, restaging, and Rx monitoring of breast
    cancer
  • Detection of TG/RAI thyroid cancer
  • Staging of cervical cancer ( CT/MRI outside
    pelvis)
  • All other cancers/indications
  • National registry

3
NOPR
  • Is a CMS-approved
  • Coverage with Evidence Development Program
  • Developed for the November 2004 expansion by CMS
  • All other cancers and indications except
  • Breast cancer diagnosis and axillary staging
  • Melanoma regional nodal staging
  • All PET facilities can participate (for a fee)
  • Requires timely Pre-PET and Post-PET information
  • All data will be submitted to CMS
  • Cases with patient and physician consent will be
    used by the NOPR to assess change in intended
    management

4
NOPRNational Oncologic PET Registry
NOPRNational Oncologic PET Registry
Sponsored by
Advisor
Managed by
Endorsed by
5
Objectives Goals
  • Objectives
  • Assess the effect of PET on referring physicians
    plans of intended patient management
  • across a wide spectrum of cancer indications for
    PET that are currently not covered by the
    Medicare program, and
  • in relation to cancer-type, indication,
    performance status, physicians role in
    management, and type of PET.
  • Goal
  • Acquire data that can be used to evaluate PET in
    a manner that does not interfere with patient
    clinical care and minimizes the burden to the
    patient, PET center, and referring physician.

6
Data Analysis and Expected Results
  • Data analyzed by cancer type and indication
    (reason for PET).
  • For the most frequent cancer indications, interim
    analysis will be performed at N200 to refine
    sample size estimates.
  • If the frequency of change in intended management
    for a particular cancer indication is sufficient
    to suggest benefit, data (along with summary of
    published literature) will be provided to CMS
    with request for coverage.
  • Eventual goal is to achieve broad coverage
    through analysis of data across all cancers and
    indications.

7
Institutional Review Board (IRB) Approval
Subject Informed Consent
  • Is this research? Yes, but only for the NOPR.
    Individual PET facilities and referring
    physicians are not engaged in research.
  • Is IRB approval needed? Yes. ACR IRB has
    approved the NOPR. Individual PET facilities and
    referring physicians do not need to obtain IRB
    approval to participate.
  • All data will be sent to CMS. CMS is not engaged
    in research.
  • Patients and referring physicians will be given
    an IRB-approved information sheet and asked for
    oral consent to have their data included in NOPR
    research.
  • Only cases where both patient and physician give
    consent will be included in the NOPR research
    dataset.

8
Patient Informational Sheet
Available at CancerPETregistry.org
  • Available in English and Spanish

Referring Physician Information Sheet
  • Also Sent with Post-PET Form to Referring
    Physician

9
HIPAA Requirements
  • HIPAA requirements met through execution of a
    Business Associates Agreement with the American
    College of Radiology as an agent for the Academy
    of Molecular Imaging and CMS.

10
Participation Requirements - PET Facilities
  • Any PET facility that is approved to bill CMS for
    either technical or global charges can
    participate in the NOPR.
  • Facilities are not required to have or obtain ACR
    or ICANL accreditation.

Participation Requirements - Patients
  • Medicare beneficiaries, including those with
    Medicare HMO coverage, who are referred for
    FDG-PET for essentially all oncologic indications
    that are not currently reimbursable under
    Medicare.
  • The Indications table lists the cancers and
    indications that are and are not eligible for the
    Registry.
  • Oral consent is necessary for inclusion in the
    NOPR research dataset however, no consent is
    necessary to submit data to NOPR that will be
    sent to CMS.

11
PET Facility Responsibilities
  • Collect and enter all required data through the
    NOPR Web site.
  • Patient must be registered within 14 days of the
    PET scan date
  • Give patient the Patient Information Sheet
  • Pre-PET Form must be entered by midnight of the
    PET scan date
  • PET Completion Form must be entered within 14
    days of case registration
  • The PET Report Post-PET forms must be entered
    within 30 days of scan
  • PET facility is eligible to bill CMS when all
    required data are received at NOPR Operations
    Office.

Referring Physician Responsibilities
  • Complete Pre-PET Form (5 questions) and return it
    to PET Facility prior to PET scan.
  • Complete Post-PET Form (4 - 7 questions) and
    return it to PET Facility within 30 days of PET
    scan.
  • Pre- and Post-PET forms can be returned to the
    PET facility via FAX, mail, or hand delivery.

12
Ineligible Indications
13
Cancers Indications Eligible for Entry in the
NOPR
continued on next slide
14
Cancers Indications Eligible for Entry in the
NOPR(continued)
15
Does NOPR Apply to Oncologic PET with
Radiopharmaceuticals other than FDG?
  • No

16
Facility and Patient Registration
  • Register via the NOPR Web site www.cancerPETregist
    ry.org
  • Complete Facility Registration Form
  • PET facility information including Medicare
    Provider Number
  • PET facility administrator (the individual
    responsible for managing registry activities at
    the facility)
  • Participating interpreting physician(s)
  • Equipment details
  • Submit Executed Business Associates Agreement
    (BAA)
  • 50 Facility Application Fee
  • 50 Processing Fee for Each Patient
  • Advance payment held in escrow account

17
NOPR Web Site
  • Information for
  • PET Facilities
  • Referring Physicians
  • Patients
  • Blank Forms
  • Register PET Facilities
  • Register Patients
  • PET Facility Tools
  • Case Status Reports
  • Account Balance
  • Fund Account by Credit Card

18
Pre-PET Form 5 Questions
  • Reason for the PET Scan
  • Cancer Site/Type
  • Summary of Disease Stage
  • NED, Localized, Regional, Metastatic, Unknown
  • Performance Status
  • Asymptomatic, Symptomatic, Bedridden
  • Intended Patient Management Plan

19
Pre-PET Form Specific Reason For PET
1. Check the single best match for the reason for
the PET.
  • Diagnosis To determine if a suspicious lesion is
    cancer
  • Diagnosis
  • Unknown primary tumor To detect a primary tumor
    site in a patient with a confirmed or strongly
    suspected metastatic lesion
  • Paraneoplastic To detect a primary tumor site in
    a patient with a presumed paraneoplastic syndrome
  • Initial staging of histologically confirmed,
    newly diagnosed cancer
  • Monitoring treatment response during
    chemotherapy, radiotherapy, or combined modality
    therapy
  • Restaging after completion of therapy
  • Suspected recurrence of a previously treated
    cancer

20
Pre-PET Form Intended Patient Management Plan
5. If PET were not available, your current
management strategy would be (select one)?
  • Observation (with close follow-up)
  • Additional imaging (CT, MRI) or other
    non-invasive diagnostic tests
  • Tissue biopsy (surgical, percutaneous, or
    endoscopic).
  • Treatment (if treatment is selected, then also
    complete the following)
  • Treatment Goal (check one) ? Curative
    ? Palliative
  • Type(s) (check all that apply)
  • ? Surgical ? Chemotherapy (including biologic
    modifiers)
  • ? Radiation ? Other ? Supportive care

21
Pre-PET Web Form
2.
42 Primary and Metastatic Sites Listed
22
Pre-PET Web Form continued
23
Post-PET Form 4 to 7 Questions
  • Questions Customized by Specific Reason for PET
    (Indication)
  • 4 - 7 Questions per Indication
  • Most Require a Yes or No Answer
  • 2 Questions are Repeated from the Pre-PET Form
  • Intended Patient Management Plan
  • Planned Cancer Care Provider
  • Referring Physician Consent

24
NOPR Workflow
PET Reviewed Reported
Clinical Actions Ongoing
Referring MD Requests PET
PET Done
Ask Patient For Consent
Post-PET Questionnaire Sent Includes Question
for Referring Physician Consent
Questionnaire Completed
Pre-PET Questionnaire
25
Timeline
  • Timeline available on NOPR Website.

26
Billing
  • Hold claims until all data is entered in the
    Registry
  • Notify reading physicians when all data is
    entered into NOPR and the PET facility has the
    NOPR e-mail verification

27
Timeline
No Waiting Period
Providers Bill Medicare Using Appropriate Claim
Form Codes
Hospitals Use UB/1450 Claim Form Technical Only
Non-Hospitals Use 1500 Claim Form Professional/Te
chnical/Global
28
FDG-PET Procedure and Supply Codes
2006 HCPCS Code Description
78811 Tumor imaging, positron emission tomography (PET) limited area (eg, chest, head/neck)
78812 Tumor imaging, positron emission tomography (PET) skull base to mid-thigh
78813 Tumor imaging, positron emission tomography (PET) whole body
78608 Brain imaging, positron emission tomography (PET) metabolic evaluation
A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries
29
FDG-PET/CT Procedure and Supply Codes
2006 HCPCS Code Description
78814 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization limited area (eg, chest, head/neck)
78815 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization skull base to mid-thigh
78816 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization whole body
A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries
30
For Carriers on 1500 Claim Form Use Modifier
2006 HCPCS Modifier Description
QR Item or service provided as routine care in a Medicare specified study or Medicare qualifying clinical trial
Modifier Use by Providers to Identify NOPR
Claims Use only with procedure, not necessary
with the radiopharmaceutical billed on the same
DOS as the procedure. CMS Transmittal 956,
5/19/06
31
Hospitals ONLY on 1450 Claim Form (UB)
2006 Hospital Revenue/ICD 9 CM Codes Description
0343 Diagnostic Radiopharmaceutical
0404 PET Procedures
V70.7 Examination of participants in clinical trial
V70.7 Use in the Second Diagnosis Position FL
68 From Current CMS policy CR 3741
32
A 72-year-old woman with diffuse large cell
non-Hodgkin's lymphoma is undergoing chemotherapy
with R-CHOP. PET/CT (skull-base to proximal
thigh) is requested after the second cycle of
treatment for monitoring of therapy.
Case 1
2006 Hospital Revenue Code 2006 HCPCS/ ICD 9 CM Codes Description
0404 78815 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization skull base to mid-thigh
0343 A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries
N/A 202.80 Other Lymphomas (malignant) Not otherwise specified (NOS)
33
Use of PET for Treatment Monitoring under NOPR
  • One potential problem may be collision of NOPR
    intent with individual carrier frequency limits
    for PET studies
  • Could lead to rejection of claim (or refusal of
    Medicare Advantage plan to pre-authorize study)
  • Please notify NOPR staff if this occurs!

34
A 67-year-old man has a history of glioblastoma
multiforme of left parietal lobe treated with
surgery, radiation therapy, and temazolamide.
Follow-up MRI demonstrates a new 8 mm focus of
contrast enhancement adjacent to the original
tumor bed. Brain PET is requested for restaging,
to distinguish recurrent tumor for radiation
necrosis.
Case 2
2006 Hospital Revenue Code 2006 HCPCS/ ICD 9 CM Codes Description
0404 78608 Brain imaging, positron emission tomography (PET) metabolic evaluation
0343 A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries
N/A 191.3 Malignant neoplasm of brain, parietal lobe
35
A 68-year-old woman has newly diagnosed
dermatomyositis and progressive weight loss. CT
of the chest, abdomen, and pelvis demonstrated no
evidence of malignancy. Whole-body PET/CT is
requested to detect an occult malignancy as the
cause of her paraneoplastic syndrome.
Case 3
2006 Hospital Revenue Code 2006 HCPCS/ ICD 9 CM Codes Description
0404 78816 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization whole body
0343 A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries
N/A 710.3 Dermatomyositis
N/A 783.21 Abnormal Loss of Weight
36
Advance Beneficiary Notice (ABN)
  • A PET facility can ask registry patients to sign
    an ABN. This decision is left up to each PET
    facility. However, an ABN should not be
    necessary. If patient eligibility is carefully
    checked before the patient is entered into the
    registry and before the PET scan is performed and
    if the facility works closely with its referring
    physicians to ensure that the required paperwork
    is submitted in a timely fashion, there will be
    no need to obtain ABNs.

37
Medigap Insurance for Co-Payments
  • Medigap insurance should cover the co-payment for
    a registry PET scan, as for any other Medicare
    covered service.

Managed Medicare Plans Medicare Advantage
  • Managed Medicare plans such as Medicare Advantage
    should pay any claims that would be covered by
    Medicare.
  • Follow Pre-Authorization as required by the plan

38
Will non-Medicare insurers reimburse for patients
entered in the Registry?
  • No, there are no non-Medicare insurers who have
    elected to reimburse for patients entered in the
    registry. Patients with insurance coverage other
    than Medicare, including Medicaid, are not
    eligible to participate in the NOPR.

39
Does NOPR Apply to Inpatients?
  • Yes.
  • The technical charge for a PET study on a
    Medicare inpatient is not billed directly, but is
    considered to be covered by the Diagnostic
    Related Grouping (DRG) payment to the hospital
    for that patient.
  • Inclusion of the patient in the NOPR is
    necessary, however, for professional component
    reimbursement for the PET study.

40
I have registered my facility with NOPR and have
not sent any money. What do I need to do NOW to
prepare for a smooth transition?
  • Download IRB Regulatory Materials Operations
    Manual implement the required procedures.
  • Put systems in place to identify (up front) NOPR
    patients and put triggers into billing systems to
    hold claims (back end). If external MD reading,
    ensure the reader does the same.
  • Meet/communicate with referring physicians
    regarding required forms/timelines and set up
    efficient processes prior to accepting patients.
  • Decide how your facility will handle ABNs for
    NOPR patients.
  • Print patient and physician consent information
    sheets for appropriate distribution.
  • Download and review the database instruction
    manual.

41
NOPR Working Group
  • Chair, Bruce Hillner, MD, Virginia Commonwealth
    University
  • Co-chair, Barry A. Siegel, MD, Washington
    University
  • R. Edward Coleman, MD, Duke University
  • Anthony Shields, MD, Wayne State University
  • Statistician Dawei Liu, PhD, Brown University
  • Epidemiologist Ilana Gareen, PhD, Brown
    University

NOPR Operations Office American College of
Radiology 1818 Market Street, Suite
1600 Philadelphia, PA 19103 215-717-0859 800-2
27-5463 x 4859
42
Endorsing Organizations Educational Contacts
  • Academy of Molecular Imaging
  • Sue Halliday, shalliday_at_eplushealthcare.com
  • American College of Radiology
  • Joy Brown, jbrown_at_phila.acr.org
  • American College of Radiology Imaging Network
  • Nancy Fredericks, nfredericks_at_phila.acr.org
  • Barbara LeStage, Patient Advocate, bkles_at_cox.net
  • American Society of Clinical Oncology
  • Nancy Daly, dalyn_at_asco.org
  • Society of Nuclear Medicine
  • Denise Merlino, denise_at_merlinohccc.com

43
Questions?
  • Send questions via e-mail to pet_registry_at_phila.ac
    r.org.
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